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    Clinical Trial Results:
    Phase II study with pazopanib and weekly paclitaxel in metastatic or locally advanced squamous penile carcinoma patients previously treated with cisplatin based chemotherapy

    Summary
    EudraCT number
    		 2014-003127-22
    Trial protocol
    		 ES  
    Global end of trial date
    30 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2021
    First version publication date
    15 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SOG-CPE-2014-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02279576
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SOGUG (Spanish Oncology Genitourinary Group)
    Sponsor organisation address
    Calle Velázquez, 7, planta 3, Madrid, Spain, 28001
    Public contact
    Clinical Operations Department, APICES SOLUCIONES, S.L., +34 91 816 68 04 Ext 103, juanluis.sanz@apices.es
    Scientific contact
    Clinical Operations Department, APICES SOLUCIONES, S.L., +34 91 816 68 04 Ext 103, juanluis.sanz@apices.es
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluate response rate in terms of complete and partial response (RECIST criteria version 1.1)
    Protection of trial subjects
    Not applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in the study from 13th March 2015 until 09th November.

    Pre-assignment
    Screening details
    		 Patients included in the study had confirmed histological diagnosis of penile squamous cell carcinoma, disease progression of carbo/cis-based CT, ECOG PS of 0-1 and adequate organ function.

    Pre-assignment period milestones
    Number of subjects started
    		 4
    Number of subjects completed
    		 4

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Experimental
    Arm description
    		 Patients who participated in the study received pazopanib 800mg/day orally and paclitaxel 65 mg/m2 IV every week administered 3 consecutive weeks in 28-day cycles until disease progression, investigator criteria or withdrawn consent.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib 800 mg/day

    Investigational medicinal product name
    Pacllitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 65 mg/m2, days 1, 8 and 15 in 28 days-cycle.

    Number of subjects in period 1
    		Experimental
    Started
    4
    Completed
    0
    Not completed
    4
         Disease progression
    2
         Adverse event/Disease not related
    1
         Exitus
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 4 4
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
        Adults
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 67.8 (60.4 to 73.8) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 4 4
    ECOG-PS
    Units: Subjects
        0)
    		 2 2
        1)
    		 2 2
    Histological diagnosis
    Units: Subjects
        Epidermoid carcinoma
    		 3 3
        Moderately differentiated squamous cell carcinoma
    		 1 1
    Histological grade
    Units: Subjects
        G1
    		 1 1
        G2
    		 1 1
        G4
    		 1 1
        Unknown
    		 1 1
    TNM at diagnosis: T
    Units: Subjects
        T2
    		 3 3
        Not available
    		 1 1
    TNM at diagnosis: N
    Units: Subjects
        N0
    		 2 2
        N1
    		 2 2
    TNM at diagnosis: M
    Units: Subjects
        M0
    		 4 4
    Current TNM: T
    Units: Subjects
        T1
    		 0 0
        T2
    		 4 4
        T3
    		 0 0
        T4
    		 0 0
    Current TNM: N
    Units: Subjects
        N0
    		 0 0
        N1
    		 4 4
    Current TNM: M
    Units: Subjects
        M0
    		 0 0
        M1
    		 4 4
    Previous treatments: Surgery
    Units: Subjects
        Glandectomy
    		 1 1
        Lymphadenectomy
    		 1 1
        Bilateral inguinal lymphadenectomy and partial pen
    		 1 1
        Partial penectomy
    		 1 1
    Previous treatments: Radiotherapy
    Units: Subjects
        Yes
    		 1 1
        No
    		 3 3
    Previous treatments: Chemotherapy
    Units: Subjects
        5-FU + Cisplatin
    		 3 3
        Cisplatin + Gemcitabine
    		 1 1
    Tumor location: Lungs
    Units: Subjects
        Yes
    		 4 4
        No
    		 0 0
    Tumor location: Lymphatic system
    Units: Subjects
        Yes
    		 3 3
        No
    		 1 1
    Tumor location: Skin and soft tissues
    Units: Subjects
        Yes
    		 2 2
        No
    		 2 2
    Tumor location: Bone
    Units: Subjects
        Yes
    		 2 2
        No
    		 2 2
    Tumor location: Liver
    Units: Subjects
        Yes
    		 1 1
        No
    		 3 3
    Number of locations per patient
    Units: Subjects
        2)
    		 1 1
        3)
    		 2 2
        4)
    		 1 1
    Number of lesions per patient
    Units: Subjects
        3)
    		 1 1
        4)
    		 1 1
        6)
    		 1 1
        10)
    		 1 1
    Number of cycles administered
    Units: Subjects
        2)
    		 2 2
        3)
    		 1 1
        11)
    		 1 1
    Height
    Units: cm
        median (full range (min-max))
    		 166.5 (160.0 to 172.0) -
    Weight
    Units: Kg
        median (full range (min-max))
    		 88.8 (72.0 to 115.0) -
    Time since initial diagnosis
    Units: Months
        median (full range (min-max))
    		 38.4 (6.3 to 119.4) -
    Relative dose intensity of pazopanib
    Units: Percentage
        median (full range (min-max))
    		 96 (58 to 100) -
    Relative dose intensity of paclitaxel
    Units: Percentage
        median (full range (min-max))
    		 66 (57 to 97) -

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Patients who participated in the study received pazopanib 800mg/day orally and paclitaxel 65 mg/m2 IV every week administered 3 consecutive weeks in 28-day cycles until disease progression, investigator criteria or withdrawn consent.

    Primary: Objective Response Rate

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    End point title
    		 Objective Response Rate [1]
    End point description
    Objective response has been calculated taking into account patients which has been response to treatment. 1 patient had a partial response to treatment.
    End point type
    Primary
    End point timeframe
    Every 8 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Phase II non-comparative study
    End point values
    		 Experimental
    Number of subjects analysed
    4
    Units: % of subjects
    number (confidence interval 95%)
        Partial response
    25 (0.0 to 67.4)
    No statistical analyses for this end point

    Secondary: Clinical benefit rate

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    End point title
    		 Clinical benefit rate
    End point description
    Clinical benefit has been calclutated taking into account patient which has been response to treatment and stable disease. 1 patient had partial response, 2 disease progression and 1 was not evaluable. Thus, objective response rate and clinical benefit match.
    End point type
    Secondary
    End point timeframe
    Every 8 weeks
    End point values
    		 Experimental
    Number of subjects analysed
    4
    Units: % of subjects
    number (confidence interval 95%)
        Yes (partial response + stable disease)
    25 (0.0 to 67.4)
    No statistical analyses for this end point

    Secondary: Response duration

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    End point title
    		 Response duration
    End point description
    Response duration has been calculated according the only patient that has been partial response to treatment.
    End point type
    Secondary
    End point timeframe
    Every 8 weeeks
    End point values
    		 Experimental
    Number of subjects analysed
    1
    Units: Months
    8
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Every 8 weeks
    End point values
    		 Experimental
    Number of subjects analysed
    4
    Units: Months
        median (confidence interval 95%)
    1.7 (0.0 to 8.5)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Every 8 weeks
    End point values
    		 Experimental
    Number of subjects analysed
    4
    Units: Months
        median (confidence interval 95%)
    2.6 (1.6 to 3.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Every 4 weeks
    Adverse event reporting additional description
    NCI-CTC-AE 4.03 ctriteria
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Pazopanib + Paclitaxel
    Reporting group description
    		 All patients

    Serious adverse events
    		 Pazopanib + Paclitaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 4 (75.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Investigations
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased related with pazopanib and paclitaxel
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Wound infection
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pazopanib + Paclitaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutropenia
    Additional description: 2 Neutropenia Grade 2
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    Asthenia
    Additional description: 1 Asthenia grade 1, 1 grade 2 and 1 grade 3
         subjects affected / exposed
    3 / 4 (75.00%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
    Additional description: 2 Diarrhoea Grade 1
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Nausea
    Additional description: 1 Nausea Grade 1 and 1 Grade 2.
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Alopecia
    Additional description: Alopecia Grade 1
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: 1 Decreased appetite grade 1 and 1 Grade 2
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Hypertriglyceridaemia
    Additional description: Hypertriglyceridaemia Grade 3
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Only 4 patients were included. Recruitment was not completed as expected.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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